Allen College

Procedure for Submitting

This webpage provides guidance for the submission and timeline of the Allen College Institutional Review Board (ACIRB) Review process. The principal investigator (i.e., student, faculty/staff, or external investigator who plans, leads, manages, and conducts a project) must comply with the following procedures by completing the appropriate ACIRB application form (Step Three) and submitting one copy of the signed application with all supporting documents electronically to ACIRB@allencollege.edu (Step 4). Forms submitted by student PIs must also include the contact information and signature of the supervising faculty member.

Step One: Documentation of Cooperation from Setting(s) of Research or Project

    Obtain documentation of cooperation from an authorized representative of the setting(s) where the research or project will take place. For guidance in preparing this documentation, refer to the ACIRB Template for Email documentation of Institutional Cooperation, located on the ACIRB Forms and Templates webpage. PIs are encouraged to share the template with the authorized representative who will prepare the documentation of institutional cooperation. The documentation of cooperation should contain any permission needed to access private records to collect information needed to conduct the research or project, such as student, medical, or employment records that are protected by FERPA, HIPAA, or other confidentiality policies. Any access to private records must occur in accordance with the policies of the cooperating institution(s).

    Pls conducting research or EBP/QI projects at UnityPoint Health — Allen Hospital must work with the Allen Hospital Privacy Office to obtain documentation of cooperation. Specific requirements are described on the following webpage:

    EBP/QI and Research Projects at UnityPoint Health — Allen Hospital

Step Two: Complete Training in Protection of Human Subjects

    Allen College requires all PIs and key personnel whose projects or studies involve human participants to undergo training in the protection of human subjects. The ACIRB recommends training provided by the Collaborative Institutional Training Initiative (CITI) Program. The ACIRB will also accept National Institutes of Health (NIH) Protecting Human Research Participants Training. Training must be current within the previous 5 years. For instructions on required training, go to the ACIRB Human Subjects Protections webpage.

Step Three: Complete the Appropriate ACIRB Review Application

    Three ACIRB applications are available on the Forms and Templates webpage:

    1. ACIRB Research Review Form: This form should be completed for projects that meet the definition of research (as specified on the ACIRB Definitions webpage) and qualify for expedited or full review. If the PI anticipates the project will need full ACIRB review, all materials must be submitted two full weeks (fourteen calendar days) in advance of the next scheduled ACIRB meeting. Please refer to the ACIRB Meeting Schedule webpage for the meeting dates and full review submission deadlines.
    2. ACIRB Exempt Review Form: This application may be used in place of the ACIRB Review Form for research that is exempt from IRB review. Criteria for exempt status are provided in the Code of Federal Regulations §46.104. When in doubt, the ACIRB Research Review Form can be submitted for research that may qualify for exempt status. The ACIRB makes the final decision about the appropriate level of review. If the ACIRB Exempt Review Form is filled out but the ACIRB determines that expedited or full review is needed, the PI must complete the ACIRB Research Review Form prior to the project being reviewed. For assistance determining if the ACIRB Research Review Form or the ACIRB Exempt Review Form should be completed, contact ACIRB@AllenCollege.edu.
    3. ACIRB EBP/QI Review Form: This form should be completed for review of evidence-based practice or quality improvement (EBP/QI) projects. The ACIRB makes the final decision about the appropriated level of review, so if it is determined that the project requires a higher level of review, the principal investigator may be asked to complete the ACIRB Exempt Review Form or ACIRB Research Review Form. For assistance determining if the ACIRB EBP/QI Form is appropriate, contact ACIRB@AllenCollege.edu.

Step Four: Application Submission to ACIRB@allencollege.edu

    Submit the following supporting documents by email to ACIRB@AllenCollege.edu. Files should be named using the specified convention:

    1. Appropriate ACIRB review form (Lastname, First Initial. EBPQI Form MM-DD-YY)
    2. Valid documentation of cooperation from the project setting(s), referred to in Step One, unless sent separately by email (Lastname, First Initial. Cooperation MM-DD-YY)
    3. Evidence of approved training in protection of human subjects (Lastname, First Initial. NIH Certificate MM-DD-YY). Exception: Human subjects protections training completed through Allen College’s subscription to CITI is accessible to the ACIRB and need not be submitted.
    4. Applications for review of research should include a completed ACIRB Application Checklist to document all items included in the submission (Lastname, First Initial. Checklist MM-DD-YY). The ACIRB Application Checklist can be accessed on the Forms and Templates webpage. Exception: Applications for review of EBP/QI projects do not need to include this checklist because the EBP/QI form includes a checklist.
    5. Project Proposal: Students must submit the project proposal paper approved by the project faculty advisor (Lastname, First Initial. Proposal MM-DD-YY).

Step Five:

    After completing the research, PIs must complete the project completion section of the ACIRB Project Completion or Continuation Form, available on the Forms & Templates webpage, and submit it to ACIRB@allencollege.edu. Exception: Allen College students do not need to submit this form upon completion of EBPQI projects.

Step Six:

    If the research or project is not completed within 365 days of the initial approval date, the PI must complete the continuation section of the ACIRB Project Completion or Continuation Form, available on the Forms & Templates webpage, and submit it to ACIRB@allencollege.edu. This form must be completed and submitted 30 days prior to the one-year anniversary of the initial approval date.

    Additional Information for Student PIs and Faculty Advisors:

    1. The ACIRB is responsible for making the final decision on level of review (e.g. EBP-QI, exempt, expedited, or full review).
    2. The ACIRB reserves the right to request further information or to ask questions of the PI regarding information that was submitted. Applications that need corrections or revisions will be returned to the PI from the ACIRB chair within 7 business days from the initial submission and will be reviewed after resubmission at a future meeting. Applications that are not resubmitted within 90 days of original notification will be void.
    3. Student PIs should carbon copy (CC) the faculty advisor on all electronic communication with the ACIRB and should work closely with the faculty advisor during the review process.
    4. Faculty advisors are required to CC the PI on any submissions made to the ACIRB on behalf of the PI.